Phase 3: testing Pelabresib for Primary Myelofibrosis (PMF)
The purpose of this trial is to evaluate whether treatment with pelabresib in combination with ruxolitinib leads to improved clinical outcomes compared to ruxolitinib alone in patients with primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF), or post-essential thrombocythemia myelofibrosis (PET-MF) who have not previously received Janus kinase (JAK) inhibitor therapy.
Official registry: https://clinicaltrials.gov/study/NCT07357727 · Novartis Pharmaceuticals · enrollment listed as 460
What this phase means
Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Pelabresib, Ruxolitinib, or Placebo. The registry lists allocation as randomized. The purpose of this trial is to evaluate whether treatment with pelabresib in combination with ruxolitinib leads to improved clinical outcomes compared to ruxolitinib alone in patients with primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF), or post-essential thrombocythemia myelofibrosis (PET-MF) who have not previously received Janus kinase (JAK) inhibitor therapy.
They plan to enroll about 460 people at 160 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
A Phase 3, Randomized, Double-blind, Active-control Study of Pelabresib (DAK539) and Ruxolitinib vs. Placebo and Ruxolitinib in Adult Patients With Myelofibrosis Who Are JAK Inhibitor Naive
Interventions: Pelabresib, Ruxolitinib, Placebo
Primary outcome (registry wording): Number of Participants with Splenic Response (SVR35) by Central Radiology Reads at Week 24 in participants with baseline total symptom score (TSS) ≥ 25
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- DIPSS risk category of intermediate-1, intermediate-2 or high-risk
- Spleen volume ≥ 450 cm3 by CT or MRI scan (local read sufficient if no central read available)
- Have an average TSS of ≥15 within 7 days prior to randomization, using MFSAF v. 4.0 (at least 4 out of 7 TSS assessments required for average calculation)
- Participants with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
- Blasts \<5% in peripheral blood. Assessment of blasts in peripheral blood is mandatory at screening
- Platelet count ≥ 100 x 10\^9/L in the absence of growth factors or transfusions for the previous 4 weeks
Who the registry excludes
- Prior splenectomy at any time or splenic irradiation in the previous 6 months
- Prior hematopoietic cell transplant or participant anticipated to receive a hematopoietic cell transplant within 24 weeks from the date of randomization
- Blasts ≥ 5% in bone marrow if results available at screening or history of accelerated phase (AP) or leukemic transformation
- History of a malignancy (other than MF, PPV-MF or PET-MF) in the past 3 years in need of systemic treatment
- Received any approved or investigational agent other than hydroxyurea or anagrelide for the treatment of MF within 14 days of first dose of study treatment or within 5 half-lives of the approved or investigational agent, whichever is longer
- Prior treatment with any JAK inhibitor or Bromodomain and extraterminal domain (BET) inhibitor
- Other protocol-defined inclusion/
Public study contact (from the registry)
Novartis Pharmaceuticals
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
160 listed- Rocky Mountain Cancer Centers — Denver, Colorado (recruiting)
- Yale University School Of Medicine — New Haven, Connecticut (recruiting)
- Florida Cancer Specialist South Reg — Fort Myers, Florida (recruiting)
- The Anderson Family Cancer Institute — Jupiter, Florida (recruiting)
- Miami NS Ins Baptist Health S FL — Miami, Florida (recruiting)
- Florida Cancer Specialists-North — St. Petersburg, Florida (recruiting)
- Florida Cancer Specialists East — Stuart, Florida (recruiting)
- Winship Cancer Institute of Emory University — Atlanta, Georgia (recruiting)
- University of Chicago Hospital — Chicago, Illinois (recruiting)
- Franciscan Health Indianapolis — Indianapolis, Indiana (recruiting)
- American Oncology Partners PA Center for Cancer and Blood Disorders — Bethesda, Maryland (recruiting)
- Summit Medical Group Oncology — Berkeley Heights, New Jersey (recruiting)
+ 138 sites outside the US on the same record
FAQ about this NCT record
Is NCT07357727 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07357727?
Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07357727?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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